BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 22358177 · Received June 30, 2025

    Report

    Report Number
    3002809144-2025-00209
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 12, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740130534
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER CHARACTER LIMIT WAS MAXED; THE FULL ID IS (B)(6). NO ADDITIONAL PATIENT INFORMATION AVAILABLE. SECTION E1 PHONE NUMBER CHARACTER LIMIT WAS MAXED, THE FULL PHONE IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20/-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/-31, AND 510K/PMA/BLA OF K052000. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW AND LABELING REVIEW. NO RETURN SPECIMENS WERE PROVIDED BY THE CUSTOMER. A REVIEW WAS PERFORMED FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE. THE REVIEW OF THIS DATA DID NOT IDENTIFY INCREASED COMPLAINT ACTIVITY FOR COMPLAINT LOT OR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT ISSUE. HISTORICAL PERFORMANCE REVIEW OF REAGENT LOT 71454FP00 WAS EVALUATED USING WORLD WIDE DATA FOR ALINITY I CA 19-9XR ASSAY WITH NO UNUSUAL REAGENT LOT PERFORMANCE IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I CA19-9XR RESULTS. SID (B)(6) GENERATED >1200.00 NG/ML, REPEATED <20.60, 6.95, 6.26 NG/ML. IT IS UNKNOWN IF THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I CA19-9XR RESULTS. SID (B)(6) GENERATED >1200.00 NG/ML, REPEATED <20.60, 6.95, 6.26 NG/ML. IT IS UNKNOWN IF THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756050 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 71454FP00 00380740130534

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)